Study shows positive results for novel, patient-controlled transdermal system (PCTS)...

Raritan, NJ February 24, 2004 -- A study evaluating a novel, patient-controlled, needle-free system for delivering pain medication to post-operative patients through the skin found that those who were on the patient-controlled transdermal system (PCTS) withdrew from pain treatment less often because of inadequate pain control versus placebo.

The study, which was published in the February issue of the journal Anesthesia & Analgesia found that 25.4% of patients who received E-TRANS Fentanyl HCI Patient-Controlled Transdermal System (PCTS), an investigational needle-free system being studied for post-surgical pain, withdrew from treatment because of inadequate pain control compared with 40.4% in the placebo group [p<0.05].

E-TRANS Fentanyl HCI PCTS is a self-contained, pre-programmed system approximately the size of a credit card. The system was designed to provide patients with personal control over their pain management requirements without the lines, needles, poles and pumps required by currently available intravenous PCA systems. Designed to adhere to a patient's upper arm or chest, E-TRANS Fentanyl HCl PCTS uses low-intensity electrical current -- which cannot be felt by the patient -- to deliver medication directly into the skin.

Patients control E-TRANS Fentanyl HCl PCTS at the push of a button, and the system immediately delivers a small dose of the short-acting analgesic fentanyl, a prescription pain medication that has been used safely and effectively for more than 30 years.

If approved by the U.S. Food and Drug Administration (FDA), E-TRANS Fentanyl HCl PCTS will be utilized in the management of acute pain requiring opioid analgesia.

"It is important that we explore new approaches and technologies to improve patients' comfort in the post-surgical setting," said study investigator Jacques E. Chelly, MD, PhD, Vice Chair of Clinical Research and Director of Orthopedic Anesthesia and Acute Pain Services, Department of Anesthes


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